Gaijin Panty

Opioid abuse and addiction in America has reached epidemic heights. As a nation, we’re spending more than $500 billion annually in health and social costs to combat this growing problem. What’s more, the Department of Health and Human Services reports more than 40,000 lives lost in 2016 from overdosing on these pain management treatments.

Long-term solutions to combating this crisis will depend upon biomedical innovation and the development of novel and safer, next generation therapies to treat both pain and addiction.

Last week, the House of Representatives passed important legislation designed to help address this epidemic and to ensure that more innovative treatments are available to patients. The bill, H.R. 6 (the Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment – SUPPORT – for Patients and Communities Act), included several of BIO’s recommendations pertaining to enhancing and improving the ability to utilize expedited approval pathways, which is an important step in getting new innovations to patients.

Specifically, the SUPPORT for Patients and Communities Act would require the Food and Drug Administration (FDA) to hold a public meeting within one year and update or develop new guidance documents covering topics such as:

• The use of innovative clinical trial designs, real world evidence, and patient experience data for the development of therapies for treating pain and addiction;
• Eligibility criteria for Sponsors to qualify for expedited approval pathways;
• Methods for evaluating acute and chronic pain; and
• Possible endpoints for use in clinical trials for pain and addiction therapies

By clarifying these points and the criteria for expedited approval qualifications, we can encourage greater investment into the development of much-needed novel and safer therapies.

The reality is that it often is not clear to companies who are developing therapies in this area as to whether they qualify for expedited approval pathways or what the FDA’s expectations are for qualifying for such pathways. Additionally, inefficient tools for evaluating pain, like the current “1-10 scale” which does not consider acute versus chronic pain, pain perception, or other comorbidities such as depression and a lack of endnotes makes clinical trials for pain and addiction therapies more difficult.

The legislation, by providing Industry Sponsors and investors a clear path forward through regulatory clarity, would also help support the discovery and utilization of less-addictive medicines – a critical component of a comprehensive plan to solve the opioid crisis.

To date there have been several bills introduced in both Chambers to fight against this growing crisis and we applaud Congress’ hard work in advancing these critical pieces of legislation.

BIO will continue working to promote policies to fight this disease by encouraging the research and development, as well as the timely approval of, and patient access to, novel medicines that improve the way we treat pain and addiction for current and future generations.

For more information about the biopharmaceutical industry’ commitment to combatting the opioid crisis, please visit http://www.bio.org/opioid.